The present invention relates to a tamper-proof container and cap assembly and related methods by tamper-proofing a container and cap assembly.
It is desirable to provide a container and cap assembly that can produce a tamper-proof seal. For example, during forensic and laboratory applications such as drug and alcohol testing, uses of such containers desire a tamper-proof seal to establish the integrity of the specimens. Consequently the so-called xe2x80x9cchain of custodyxe2x80x9d of the contents of the container is visually maintained.
The present invention relates to a tamper-proof container and cap assembly comprising a container and a cap. The purpose of the present invention is to produce a container that allows a user to fill the container with the desired material (e.g. blood, urine). Subsequently, the user closes the cap of the container and engages a tamper-proof indicator.
In one embodiment, the container has an upper portion and an outer surface. The container has a rim at the upper portion. The upper portion of the container includes a flexible and detachable protrusion having a contact element and a break point. In another embodiment, the cap has a base with an outer periphery and a skirt extending perpendicularly and outwardly around the outer periphery of the base. The cap also has a hinge and a tab extending perpendicularly and outwardly from the skirt of the cap. In still another embodiment, the top has a least two slots capable of housing the protrusion. In yet another embodiment, the cap has a first slot and a second slot including an interlocking device for engaging with the protrusion.
In a further embodiment, when the container is in an empty stage, the protrusion is positioned within the first slot. In still a further embodiment, when the container is in a filled stage, the cap is placed upon the container and the protrusion is repositioned within the second slot causing the contact element of the protrusion to engage the interlocking device of the second slot and thus to form a tamper-proof seal. For purposes of this invention, the term xe2x80x9cempty stagexe2x80x9d refers to a stage when the container is empty prior to filling. For example, when the container is shipped to a laboratory from the manufacturer of the container. The term xe2x80x9cfilling stagexe2x80x9d refers to a stage after the container has been filled with its content. In one embodiment, the contents may include specimens such as blood samples, urine samples or other bodily fluids of a patient. In yet another embodiment, the protrusion is formed in such a way that, if the cap is opened (i e. tampered with), the protrusion will break off and thus, evidence of tampering with the container will be evident by the broken protrusion. It will be appreciated that it may not be possible to replace the protrusion once it has broken, since the protrusion is formed integrally with the container. Therefore, it should not be possible to defeat the tamper-proof capabilities by replacing the original broken protrusion. It will also be appreciated that the interlocked protrusion not only provides a tamper-proof function, but also may aid in preventing dislodgement of the cap during transport.
For purposes of the present invention, the phrase xe2x80x9ctamper-proof sealxe2x80x9d means a visual indication that: (a) when not broken, the container""s cap has not been opened; and (b) when broken, the container cap has been opened and thus, visually displays that the container was tampered with.
In another embodiment, the present invention relates to a method of tamper-proofing a container and a cap assembly by: (a) providing a container have an upper portion and an outer surface, the upper portion having a flexible and a detachable protrusion having a contact element and a break point; and a cap having a base with an outer periphery and a skirt extending perpendicularly and outwardly around the outer periphery of the base, the cap has a hinge and a tab extending perpendicularly and outwardly from the skirt of the cap, the tab comprising a first and second slot capable of housing the protrusion, the second slot having an interlocking device; (b) positioning the protrusion within the first slot in an empty stage; (c) opening the cap and filling the container; and (d) closing the cap upon the container and repositioning the protrusion within the second slot thereby allowing the contact element of the protrusion to engage the interlocking device to from a tamper-proof seal.
In yet another embodiment, the method further comprises applying a sufficient frontal, upward force upon the tab to allow the interlocking device of the slot to engage the contact element of the protrusion and thus to detach the protrusion from the flange at the break point to thereby breach the seal.